The ultimate aim of this project is to develop a CE-marked and/or FDA-approved diagnostic platform for viral load monitoring of HIV-1 infected patients in point-of-care (POC) and resource- limited settings. Currently available viral load tests are not suitable for such settings due to their inherent high cost, complexity and size, thus patients, especially in the developing world, are often not monitored for treatment efficacy. However, estimation of viral load in HIV-1 patients receiving anti-viral treatment (ART) is considered the best marker for the initiation and monitoring of ART. Diagnostics for the Real World (DRW) has developed a POC platform called SAMBA (Simple AMplification Based Assay) and proposed to develop a SAMBA HIV-1 semi-quantitative viral load test for plasma and whole blood samples. This semi-quantitative test will distinguish patients with viral loads above or below a predetermined clinically relevant cut-off to aid clinicians to monitor non-compliance, treatment efficacy or treatment failure due to the development of resistance. This Phase I proposal is to further develop and optimize the chemistry for plasma and low volume whole blood samples, and assess the proposed 1,000 copies/ml cut-off with in-house testing of clinical samples. The assay and the validity of the cut-off at 1,000 copies/ml will also be evaluated in-house in whole blood samples, to be followed by a field trial in Malawi in samples from patients under going ART. Confidential information: patent application in process